The WSJ reports today that the “EU backs Avastin for breast cancer” in “stark contrast to the recent verdict by the US Food and Drug Administration.” I blogged about the FDA decision last December, so go read that first for background.
The WSJ leaves you with the impression that the EU is a better place to be a breast cancer patient – as soon as they realize their mistake, expect the story to be pulled.
A couple of serious points about this news: The EMA committee had already agreed to this back in December (as the WSJ noted). Now we know the Commission agrees. The decision means “Avastin (bevacizumab) in combination with paclitaxel will remain a treatment option for women with metastatic breast cancer in Europe.” (from the Roche press release – still looking for the actual EC document).
Of course, that is true in the US as well – the FDA merely recommended that the Avastin label be changed to remove the indication for metastatic HER2-negative breast cancer. It can still be prescribed off-label, like many cancer medications. And the FDA will have a public hearing on June 28-29, 2011 (FDA-2010-N-0621), where Roche/Genentech will present their studies on the safety and efficacy of Avastin for metastatic HER2-negative breast cancer. One hurdle for the company will be the recent review article in JAMA, demonstrating statistically significant increased mortality with Avastin. In the mean time, nothing changes in the US.
The US and the EU have different regulatory processes to evaluate the science, but both currently pay for Avastin for breast cancer. Most importantly, the US process isn’t over. If we’re serious about cost savings in health care, we need to listen to the evidence.